Tuesday, July 29, 2008

News!

New law aims to distance the FDA from the drug industry

Jeanne Lenzer

New York

Legislation aimed at ending the close relationship between theUS Food and Drug Administration and the drug industry was introducedlast week in the House of Representatives by Congressman MauriceHinchey (Democrat) of New York.

The Food and Drug Administration Improvement Act 2005 has beenendorsed by the Center for Science in the Public Interest inWashington, DC, a non-profit education and advocacy organisation.Merrill Goozner, director of the centre's integrity in scienceproject, said it was "exactly what is needed to restore publicconfidence in the FDA."

The bill includes several provisions aimed at ending financialconflicts of interest. Drug companies would still be expectedto pay fees but they would be paid to a general fund of theUS Treasury. The bill prohibits the FDA from negotiating withdrug companies about how it uses funds and it "terminates allprevious agreements between FDA and such companies."

The bill would also prohibit scientists with financial conflictsof interest from sitting on FDA advisory panels.

Furthermore, it would establish a separate centre for post-marketdrug safety and effectiveness, so that "different doctors andscientists than the ones who approve a drug will monitor itssafety once it hits the market."

If passed, the bill would overturn provisions of the PrescriptionDrug Users Fee Act (PDUFA), first passed in 1992, which establisheda schedule of payments by the drug industry to the FDA.

Mr Hinchey said, "[PDUFA] was initiated during the first Bushadministration, allegedly to speed up the approval of drugs,but what it did—and what I think they knew it would do—wasto establish a close relationship between the regulatory agencyand the industry it is supposed to regulate. Right now, almost50% of the FDA drug budget is funded by the drug industry.

"And the ridiculous part is that the FDA has to negotiate withdrug companies about how they use this money. It creates a relationshipthat is contrary to the whole idea of what the FDA is supposedto be."

The bill would redirect drug company fees to a general fundof the US Treasury and would create mandatory funding levelsto support the FDA. It would also prohibit the FDA from negotiatingwith drug companies and "terminates all previous agreementsreached between FDA and such companies."

Other provisions of the bill would empower the FDA to mandatepost-marketing studies, demand label changes, and impose penaltiesof up to $50m (£27m; 39m) against companies that violateFDA drug regulations.

A controversial legal stance at the FDA known as "pre-emption"(bmj.com; 8 Jan 2005, News Extra) that was introduced by theformer chief counsel to the FDA, Daniel Troy, would also bereversed under the bill. Mr Troy argued that manufacturers ofdrugs that were approved by the FDA could not be held liablefor adverse outcomes unless the company committed outright fraud.

The FDA does not comment on legislation. The PharmaceuticalManufacturers and Research Association had not responded torequests for interviews at the time the BMJ went to press.